FDA.reportPublic FDA data

MINERAL BASED SPF 50 SUNSCREEN

Manufacturer
THE KROGER COMPANY
Effective date
2024-10-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:25:49

Key Label Information#

Active Ingredients And Purpose

Active ingredients

Titanium Dioxide 7.0%, Zinc Oxide 4.7%

Purpose

Sunscreen

Uses

Uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

Warnings

For external use only

Do not use

on damaged or broken skin.

Stop use and ask a doctor if

rash occurs.

Directions And Dosage

Directions

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses

Other Label Information

Inactive ingredients

beeswax, butyloctyl salicylate, caprylyl glycol, cetyl alcohol, euphorbia cerifera (candelilla) wax, isopropyl palmitate, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, paraffin, silica

Label

SIMPLE TRUTH KIDS' MINERAL BASED STICK SPF 50 SUNSCREEN 30142-881-01 SIMPLE TRUTH KIDS' MINERAL BASED STICK SPF 50 SUNSCREEN BLISTER PACK 30142-881-91

Label Images#

Label
Label
Blister
Blister

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-881-01MINERAL BASED SPF 50 SUNSCREEN13.3 g in 1 CONTAINERSTICK13.34
30142-881-91MINERAL BASED SPF 50 SUNSCREEN1 in 1 BLISTER PACKSTICK14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-881MINERAL BASED SPF 50 SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) STICK [THE KROGER COMPANY]4Current NDC, Legacy NDC, 2 package rows20241017_a4e6936d-a76c-e8fd-e053-2995a90a965f.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-88130142-881-01, 30142-881-91

Ingredients#

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL PALMITATE8CRQ2TH63MIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CETYL ALCOHOL936JST6JCNIACT
CANDELILLA WAXWL0328HX19IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
CERESINQ1LS2UJO3AIACT
WHITE WAX7G1J5DA97FIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ISOSTEARIC ACIDX33R8U0062IACT
PARAFFINI9O0E3H2ZEIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

Complete SPL Sections#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7.0%, Zinc Oxide 4.7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses

Other information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun may stain or damage some fabrics, materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

beeswax, butyloctyl salicylate, caprylyl glycol, cetyl alcohol, euphorbia cerifera (candelilla) wax, isopropyl palmitate, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, paraffin, silica

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIMPLE TRUTH KIDS' MINERAL BASED STICK SPF 50 SUNSCREEN 30142-881-01 SIMPLE TRUTH KIDS' MINERAL BASED STICK SPF 50 SUNSCREEN BLISTER PACK 30142-881-91

Source Document#

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